510(k) K211684 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
| Applicant | Given Imaging Ltd. (Medtronic), Yoqneam Northern, IL |
| Decision | Substantially Equivalent, Aug 27, 2021 |
| Received | Jun 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211684
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.